Events

Recall of Device Recall Integra

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Integra LifeSciences Corp..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76693
  • Event Risk Class
    Class 2
  • Event Number
    Z-1539-2017
  • Event Initiated Date
    2017-03-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-05-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153928
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Reason
    Voluntary recall/removal of panta and panta xi nails because there may be the potential that the internal and external package seal does not provide the level of sterility intended.
  • Action
    Integra sent "Urgent Medical Device Recall Letters and Return Response Forms" dated March 3, 2017 to their distributors and customers. All customers were asked to examine their inventory to determine if they had the recalled lots and if they did they are instructed to stop using them immediately. Distributors are asked if the recalled product was further distributed, those customers should be notified and instructed to follow the recalling procedures. The return response form should be completed, even if they do not have any recalled lots, annotating the amount of product and list a record of the lot numbers. The return response form should be sent back to Integra via email to: FCA2@integralife.com or via fax to: 1-609-750-4220. Upon receipt by Integra, if your company has identified recalled lots, Customer Service will contact the customer and provide an RMA number and directions to return the product, as well as input an order to replace the quantity indicated on the return response form. Should any customer have any questions regarding the recall instructions, they can contact Customer Service at 1-800-654-2873. To return units under field inventory, customer can contact 1-888-601-0203, option 2. For further questions, please call (717) 309-3966.

Device

Device Recall Integra
  • Model / Serial
    Panta Nails -  Reference/Model #500050ND - Lot #'s: F33A, F33B, F3BN, F3Y5, F3Y6, F4S4, F56Y, F5LZ, F64W, F7C8, F7C9, F8SZ, F9PC, FCUG, FCUH, FEDW, FEVR, FGAX, FGLN and FHLP;  Reference/Model #500080ND - Lot #'s: F0F1, F64X, F81Y, F81Z, FEVS, FGLP and FGSK;  Reference/Model #500150ND - Lot #'s: F15L, F15L/1, F1ZQ, F27U, F27V, F3Y7, F5M0,F60W, F64Y, F64Z, F6L3, F7CA, F7CB, F7CC, F7CD, F821, F822, F8T1, F8T2, F9D6, F9D7, FEDX, FFB9, FG4T, FGSL and FHLR;  Reference/Model #500180ND - Lot #'s: F1ZS, F33C, F3M9, F4H4, F4ZZ, F68B, F823, F824, F8T3, FDEC, FEDY, FFBA and FFQL;  Reference/Model #500250ND - Lot #'s: EP14, F0WQ, F15M, F4H5, F500, F5M1, F650, F825, F826, F827, F828, F8T4, FGLQ and FGSM;  Reference/Model #500280ND - Lot #'s: F27T, F33D, F3BP, F3MA, F4H6, F5M2, F6L4, F829, F82A, F82B, F82C, F8T5 and FFBB;  Reference/Model #500350ND - Lot #'s: E2W1/1, F3BQ, F3MB, F3MD, F3Y8, F4H7, F5M3, F651, F6TT and FF3B;  Reference/Model #500380ND - Lot #'s: F3BR, F3MC, F4S5, F5M4, F60X, F652, F82D, F82E, F8T6 and FAF2  Panta XL Nails -  Reference/Model #510111ND - Lot #'s: F3H8, F4XA, F507, F5M5, F68C, F82F, F82G, F8T7, F9DC and F9DD;  Reference/Model #51014ND - Lot #'s: ELSS, EPFZ, F3H9, F82H, F82J, F8LG, FEVT and FFBC;  Reference/Model #510211ND - Lot #'s: F6JA, F82K, F82L, F8C8, F8T8, FFQN and FG4V;  Reference/Model #510241ND - Lot #'s: F5M6, F82M, F82N, F8C9 and F8T9;  Reference/Model #510311ND - Lot #'s: EPG0/1, EPG0/2, EPG0/3, EPG0/4, EPG0/5, F82P, F82Q and F8TA;  Reference/Model #510341ND - Lot #'s: F4H8, F508, F657 and F8TB
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide and Internationally
  • Product Description
    Panta Nail, Rx only, Sterile,
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.